Olmesartan Medoxomil and Hydrochlorothiazide

Product NDC
57664-760
11-digit product format
576640760
Labeler code
57664
Product ID
57664-760_5784665f-83c5-4153-937a-61d0f1e2483b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil-hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA021532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-26
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength
40 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-760-83EA - Each57664-760b547b367-e952-41ba-bf32-67942bcef81112016-11-08
57664-760-99EA - Each57664-76042957693-4cc2-4233-82b5-c8ac50e25b8512016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-760-835766407608330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-760-83) 2016-10-260000-00-00NoNoCurrent
57664-760-995766407609990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-760-99) 2016-10-260000-00-00NoNoCurrent